Manufacturing

The agency is requiring companies that make sartan blood pressure drugs to review their manufacturing processes due to the problem with impurities.

PCI Pharma Services expanded capacity of its commercial packaging site in Illinois.

In a deal potentially worth up to $460 million, Genentech and Xencor will develop and commercialize novel cytokine therapeutics.

The RK-1 continuous mixing processor from Readco Kurimoto is suited for testing formulations in continuous processing conditions.

Spectroscopic-based control methods were introduced as equivalent alternative methods, first to a gas chromatographic method to monitor an in-process solvent exchange step and second to a potentiometric titration method to release a process input material for drug substance manufacturing.

Storage and retrieval methods and the unique requirements found in building codes are crucial considerations.

Using a QbD approach in the development and formulation of topical products will enable the drug developer to provide a robust control strategy for manufacturing.

The Flexicon FPC60 peristaltic fill/finish system from Watson-Marlow Fluid Technology Group can use a variety of modules that allow users to create their own customized filling solution to suit small-batch applications.

Robotic isolators and single-use technologies are gaining ground, according to aseptic processing consultant Jim Agalloco.

Technical advances in process understanding and control must be accompanied by a change in mindset.

ChargePont Technology has revealed that it is now able to expand its smart monitoring technology into North America thanks to being granted HazLoc (Hazardous Area) certification.

The acquisition will boost Hitachi Chemical’s presence in the European regenerative medicines market.

Janssen and MeiraGTx will collaborate on the development and commercialization of gene therapies for treating inherited retinal diseases.

Tech transfer is key to succession advancing biopharmaceutical pipeline products from research to preclinical.

New alert customization and expanded Open Platform Communication support in Emerson’s DeltaV Mobile app improve notification and third-party system monitoring.

Parker Bioscience Filtration added a cleanroom at its site in Birtley, UK for manufacturing single-use assemblies and sensors used in biopharmaceutical processing.

TC BioPharm (TCB), developer of CAR-T immuno-oncology products, has completed its first allogenic Gamma Delta T (GDT) cell banks.

Full commercial launch of the drug is underway in the United States, with Europe to follow.

G-CON will provide a complete cleanroom infrastructure for GE Healthcare’s cell therapy and viral vector production platforms that will simplify early-stage manufacturing efforts.

Following the defeat of the UK's Prime Minister’s proposed Brexit withdrawal deal, substantial uncertainty around Brexit remains and risks to public heath and the economy are mounting.

MilliporeSigma’s use of modified amino acids can simplify the fed-batch process in biomanufacturing.

The EU FMD deadline is closing in, so now is the time to look beyond the short term.

Univercells, a business-to-business provider focused on biologics, has commercially launched its proprietary bioproduction system, NevoLine.

The Centre for Process Innovation (CPI) has led an Innovate UK project focused on the establishment of a generic framework and core capability to improve industrial productivity using computer models.

Almac Sciences has announced the expansion of its technology capabilities within its API services and chemical development portfolio through implementation of continuous flow expertise.

Modular and podular laboratory and manufacturing allow rapid reconfiguration to support development of drugs for diverse patient populations.

The agreement gives Sanofi access to Biomunex’s proprietary bi- and multi-specific-antibody-generating platform.

Pharmaceutical Technology spoke with CatSci Ltd about what their manufacturing process unique.

The company is set to expand biologics and fill/finish capacity at its biologics manufacturing sites in Madison, WI, and Bloomington, IN.

The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) revealed 22 new projects and funding aimed to advance US biopharmaceutical manufacturing.